SummaryContinued improvement in the nation's health depends upon the efficient development of affordable replacement human tissue and related therapies; an acute shortage of willing organ donors and the shortcomings of conventional therapies leads to the preventable death of many patients each year. The next healthcare revolution will apply regenerative medicines, creating biological therapies or substitutes for the replacement or restoration of tissue function lost through failure or disease. However, whilst science has revealed the potential, and early products have shown the power of such therapies, there is now a need for the long term supply of people properly trained with the necessary skills to face the engineering and life science challenges before the predicted benefits in human healthcare can be realised. Because the products arising from this technology differ significantly from those made by mainstream pharmaceutical companies, training programmes currently available are poorly equipped to meet the demand for increasing numbers of appropriately trained personnel. We estimate that the number of engineers with the necessary skills to interact `on the same level' with cutting edge bioscientists and clinicians is very small, perhaps no more than 100 nationally; in such a small community 50 newly trained PhD's will have a very large impact. Here we propose a new UK based DTC in Regenerative Medicine integrated across three Universities with highly complementary expertise where students will be trained in the core skills needed to work at the life science/engineering interface and then engaged in strategic research programmes designed to address the major challenges in the field. This will ensure that the necessary people and enabling technologies are developed for the UK to lead in this rapidly growing worldwide marketplace.

Biomedical Materials have advanced dramatically over the last 50 years. Historically, they were considered as materials that formed the basis of a simple device, e.g. a hip joint or a wound dressing with a predominant tissue interface. However, biomedical materials have grown to now include the development of smart and responsive materials. Accordingly, such materials provide feedback regarding their changing physiological environment and are able to respond and adapt accordingly, for a range of healthcare applications. Two major areas underpinning this rapid development are advances in biomedical materials manufacture and their characterisation. Medical products arising from novel biomedical materials and the strategies to develop them are of great importance to the UK and Ireland. It is widely recognised that we have a rapidly growing and ageing population, with demand for more effective but also cost effective healthcare interventions, as identified in recent government White Paper and Foresight reports. This links directly to evidence of the world biomaterials market, estimated to be USD 70 billion (2016) and expected to grow to USD 149 billion by 2021 at a CAGR of 16%. To meet this demand an increase of 63% in biomedical materials engineering careers over the next decade is predicted. There is therefore a national need for a CDT to train an interdisciplinary cohort of students and provide them with a comprehensive set of skills so that they can compete in this rapidly growing field. In addition to the training of a highly skilled workforce, clinically and industrially led research will be performed that focuses on developing and translating smart and responsive biomaterials with a particular focus on higher throughput, greater reproducibility of manufacture and characterisation. We therefore propose a CDT in Advanced Biomedical Materials to address the need across The Universities of Manchester, Sheffield and The Centre for Research in Medical Devices (CÚRAM), Republic of Ireland (ROI). Our combined strength and track record in biomaterials innovation, translation and industrial engagement aligns the UK and ROI need with resource, skills, industrial collaboration and cohort training. This is underpinned strategically by the Biomedical Materials axis of the UK's £235 million investment of the Henry Royce Institute, led by Manchester and partner Sheffield. To identify key thematic areas of need the applicants led national Royce scoping workshops with 200 stakeholders through 2016 and 2017. Representation was from clinicians, industry and academia and a national landscape strategy was defined. From this we have defined priority research areas in bioelectronics, fibre technology, additive manufacturing and improved pre- clinical characterisation. In addition the need for improved manufacturing scale up and reproducibility was highlighted. Therefore, this CDT will have a focus on these specific areas, and training will provide a strongly linked multidisciplinary cohort of biomedical materials engineers to address these needs. All projects will have clinical, regulatory and industry engagement which will allow easy translation through our well established clinical trials units and positions the research well to interface with opportunities arising from 'Devolution Manchester', as Greater Manchester now controls long-term health and social care spending, ready for the full devolution of a budget of around £6 billion in 2016/17 which will continue through the CDT lifespan.